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ClinicalTrials.gov ID

NCT04666324

Lead Sponsor

The President Stanisław Wojciechowski State University of Applied Sciences in KaliszOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

100Estimated

Last Update Posted

Dec 14, 2020Actual

Start Date

Dec 2020Estimated

Primary Completion Date

Jun 2021Estimated

Completion Date

Sep 2021Estimated

Official Title

Effects of Simethicone and Multilac Baby on Fecal Calprotectin Levels Infantile Colic

Brief Summary

Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby on crying behavior and fecal calprotectin levels in babies diagnosed for infantile colic.

Detailed Description

Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria. Study design will be open label with two parallel arms (Simethicone and Multilac Baby). Multilac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3 bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental 24h paper diaries. Fecal calprotectin values at the beginning and at the end of the study will be evaluated using BÜHLMANN Quantum Blue® Calprotectin High Range (Schönenbuch, Switzerland), a quantitative immunoassay.

• Infantile Colic

• Simethicone Solution
• Multilac Baby

Ages Eligible for Study

Child (0-17)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria:

• previous treatment with probiotic or synbiotic
• previous treatment with antibiotics

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

The President Stanisław Wojciechowski State University of Applied Sciences in KaliszOTHER

hjk12@pczta.fm